e.cam and Symbia E gamma camera systems with patient beds To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.
FDA Recall Z-2758-2016 · Posted None
Reason for Recall
Firm Action
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution: US (Nationwide) including states of: District of Columbia and Puerto Rico and countries of: Algeria, Argentina, Austria, Australia, Bangladesh, Bahrain, Belarus, Belgium, Brazil, Cameroon, Canada, Chile, China, Colombia, Congo-The Democratic Republic of the, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Great Britain, India, Iran, Ireland, Israel, Italy, Japan, Kazakhstan, Korea, Kuwait, Lebanon, Mauritius, Malaysia, Mexico, Morocco, Myanmar, Nepal, Netherlands, Nigeria, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Spain, Serbia (Republic of Serbia), South Africa, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Uganda, United Arab Emirates, Uzbekistan, Viet nam, and Yemen.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.